Apparatus and methods for dilating and modifying ostia of paranasal sinuses and other intranasal or paranasal structures

ABSTRACT

Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.) into the paranasal sinuses or other structures in the ear, nose or throat.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/768,963, entitled “Apparatus and Methods for Dilating and ModifyingOstia of Paranasal Sinuses and Other Intranasal or ParanasalStructures,” filed on Apr. 28, 2010, issued as U.S. Pat. No. 8,945,088,which is a continuation of U.S. patent application Ser. No. 11/928,346,entitled “Apparatus and Methods for Dilating and Modifying Ostia ofParanasal Sinuses and Other Intranasal or Paranasal Structures,” filedon Oct. 30, 2007, issued as U.S. Pat. No. 8,172,828, which is acontinuation of U.S. patent application Ser. No. 10/944,270, entitled“Apparatus and Methods for Dilating and Modifying Ostia of ParanasalSinuses and Other Intranasal or Paranasal Structures,” filed on Sep. 17,2004, published as United States Patent Publication No. 2006/0004323,now abandoned, which is a continuation-in-part of U.S. patentapplication Ser. No. 10/829,917, entitled “Devices, Systems and Methodsfor Diagnosing and Treating Sinusitis and Other Disorders of the Ears,Nose and/or Throat,” filed on Apr. 21, 2004, issued as U.S. Pat. No.7,654,997, the entire disclosures of which are expressly incorporatedherein by reference.

BACKGROUND

The present invention relates generally to medical devices and methodsand more particularly to minimally invasive, devices, systems andmethods for treating sinusitis and other ear, nose & throat disorders.

The nose is responsible for warming, humidifying and filtering inspiredair and for conserving heat and moisture from expired air. The nose isformed mainly of cartilage, bone, mucous membranes and skin.

The bones in the nose contain a series of cavities known as paranasalsinuses that are connected by passageways. The paranasal sinuses includefrontal sinuses, ethmoid sinuses, sphenoid sinuses and maxillarysinuses. The paranasal sinuses are lined with mucous-producingepithelial tissue and ultimately opening into the nasal cavity.Normally, mucous produced by the epithelial tissue slowly drains out ofeach sinus through an opening known as an ostium. If the epithelialtissue of one of these passageways becomes inflamed for any reason, thecavities which drain through that passageway can become blocked. Thisblockage can be periodic (resulting in episodes of pain) or chronic.This interference with drainage of mucous (e.g., occlusion of a sinusostium) can result in mucosal congestion within the paranasal sinuses.Chronic mucosal congestion of the sinuses can cause damage to theepithelium that lines the sinus with subsequent decreased oxygen tensionand microbial growth (e.g., a sinus infection).

Sinusitis:

The term “sinusitis” refers generally to any inflammation or infectionof the paranasal sinuses caused by bacteria, viruses, fungi (molds),allergies or combinations thereof. It has been estimated that chronicsinusitis (e.g., lasting more than 3 months or so) results in 18 millionto 22 million physician office visits per year in the United States.

Patients who suffer from sinusitis typically experience at least some ofthe following symptoms:

-   -   headaches or facial pain    -   nasal congestion or post-nasal drainage    -   difficulty breathing through one or both nostrils    -   bad breath    -   pain in the upper teeth

Thus, one of the ways to treat sinusitis is by restoring the lost mucousflow. The initial therapy is drug therapy using anti-inflammatory agentsto reduce the inflammation and antibiotics to treat the infection. Alarge number of patients do not respond to drug therapy. Currently, thegold standard for patients with chronic sinusitis that do not respond todrug therapy is a corrective surgery called Functional Endoscopic SinusSurgery.

Current and Proposed Procedures for Sinus Treatment

Functional Endoscopic Sinus Surgery

In FESS, an endoscope is inserted into the nose and, under visualizationthrough the endoscope, the surgeon may remove diseased or hypertrophictissue or bone and may enlarge the ostia of the sinuses to restorenormal drainage of the sinuses. FESS procedures are typically performedwith the patient under general anesthesia.

Although FESS continues to be the gold standard therapy for surgicaltreatment of severe sinus disease, FESS does have several shortcomings.For example, FESS can cause significant post-operative pain. Also, someFESS procedures are associated with significant postoperative bleedingand, as a result, nasal packing is frequently placed in the patient'snose for some period of time following the surgery. Such nasal packingcan be uncomfortable and can interfere with normal breathing, eating,drinking etc. Also, some patients remain symptomatic even after multipleFESS surgeries. Additionally, some FESS procedures are associated withrisks of iatrogenic orbital, intracranial and sinonasal injury. Manyotolaryngologists consider FESS an option only for patients who sufferfrom severe sinus disease (e.g., those showing significant abnormalitiesunder CT scan). Thus, patients with less severe disease may not beconsidered candidates for FESS and may be left with no option but drugtherapy. One of the reasons why FESS procedures can be bloody andpainful relates to the fact that instruments having straight, rigidshafts are used. In order to target deep areas of the anatomy with suchstraight rigid instrumentation, the physician needs to resect and removeor otherwise manipulate any anatomical structures that may lie in thedirect path of the instruments, regardless of whether those anatomicalstructures are part of the pathology.

Balloon Dilation Based Sinus Treatment

Methods and devices for sinus intervention using dilating balloons havebeen disclosed in U.S. Pat. No. 2,525,183 (Robison) and United StatesPatent Publication No. 2004/0064150 A1 (Becker), now U.S. Pat. No.8,317,816, issued Nov. 27, 2012. For example, U.S. Pat. No. 2,525,183(Robison) discloses an inflatable pressure device which can be insertedfollowing sinus surgery and inflated within the sinus. The patent doesnot disclose device designs and methods for flexibly navigating throughthe complex nasal anatomy to access the natural ostia of the sinuses.The discussion of balloon materials is also fairly limited to thinflexible materials like rubber which are most likely to be inadequatefor dilating the bony ostia of the sinus.

United States patent publication number 2004/0064150 A1, issued as U.S.Pat. No. 8,317,816 (Becker) discloses balloon catheters formed of astiff hypotube to be pushed into a sinus. The balloon catheters have astiff hypotube with a fixed pre-set angle that enables them to be pushedinto the sinus. In at least some procedures wherein it is desired toposition the balloon catheter in the ostium of a paranasal sinus, it isnecessary to advance the balloon catheter through complicated ortortuous anatomy in order to properly position the balloon catheterwithin the desired sinus ostium. Also, there is a degree of individualvariation in the intranasal and paranasal anatomy of human beings, thusmaking it difficult to design a stiff-shaft balloon catheter that isoptimally shaped for use in all individuals. Indeed, rigid cathetersformed of hypotubes that have pre-set angles cannot be easily adjustedby the physician to different shapes to account for individualvariations in the anatomy. In view of this, the Becker patentapplication describes the necessity of having available a set of ballooncatheters, each having a particular fixed angle so that the physiciancan select the appropriate catheter for the patient's anatomy. Therequirement to test multiple disposable catheters for fit is likely tobe very expensive and impractical. Moreover, if such catheter aredisposable items (e.g., not sterilizable and reusable) the need to testand discard a number of catheters before finding one that has the idealbend angle could be rather expensive.

Methods and devices for sinus intervention using dilating balloons havebeen disclosed in U.S. Pat. No. 2,525,183 (Robison) and United StatesPatent Publication No. 2004/0064150 A1, issued as U.S. Pat. No.8,317,816 (Becker). For example, U.S. Pat. No. 2,525,183 (Robison)discloses an inflatable pressure device which can be inserted followingsinus surgery and inflated within the sinus. The patent does notdisclose device designs and methods for flexibly navigating through thecomplex nasal anatomy to access the natural ostia of the sinuses. Thediscussion of balloon materials is also fairly limited to thin flexiblematerials like rubber which are most likely to be inadequate fordilating the bony ostia of the sinus.

United States patent publication number 2004/0064150 A1, issued as U.S.Pat. No. 8,317,816 (Becker) discloses balloon catheters formed of astiff hypotube to be pushed into a sinus. The balloon catheters have astiff hypotube with a fixed pre-set angle that enables them to be pushedinto the sinus. In at least some procedures wherein it is desired toposition the balloon catheter in the ostium of a paranasal sinus, it isnecessary to advance the balloon catheter through complicated ortortuous anatomy in order to properly position the balloon catheterwithin the desired sinus ostium. Also, there is a degree of individualvariation in the intranasal and paranasal anatomy of human beings, thusmaking it difficult to design a stiff-shaft balloon catheter that isoptimally shaped for use in all individuals. Indeed, rigid cathetersformed of hypotubes that have pre-set angles cannot be easily adjustedby the physician to different shapes to account for individualvariations in the anatomy. In view of this, the Becker patentapplication describes the necessity of having available a set of ballooncatheters, each having a particular fixed angle so that the physiciancan select the appropriate catheter for the patient's anatomy. Therequirement to test multiple disposable catheters for fit is likely tobe very expensive and impractical. Moreover, if such catheter aredisposable items (e.g., not sterilizable and reusable) the need to testand discard a number of catheters before finding one that has the idealbend angle could be rather expensive.

SUMMARY

In general, the present invention provides methods, devices and systemsfor diagnosing and/or treating sinusitis or other conditions of the ear,nose or throat.

In accordance with the present invention, there are provided methodswherein one or more flexible or rigid elongate devices as describedherein are inserted in to the nose, nasopharynx, paranasal sinus, middleear or associated anatomical passageways to perform an interventional orsurgical procedure. Examples of procedures that may be performed usingthese flexible catheters or other flexible elongate devices include butare not limited to: remodeling or changing the shape, size orconfiguration of a sinus ostium or other anatomical structure thataffects drainage from one or more paranasal sinuses; cutting, ablating,debulking, cauterizing, heating, freezing, lasing, forming an osteotomyor trephination in or otherwise modifying bony or cartilaginous tissuewithin paranasal sinus or elsewhere within the nose; removing puss oraberrant matter from the paranasal sinus or elsewhere within the nose;scraping or otherwise removing cells that line the interior of aparanasal sinus; delivering contrast medium; delivering atherapeutically effective amount of a therapeutic substance; implantinga stent, tissue remodeling device, substance delivery implant or othertherapeutic apparatus; cutting, ablating, debulking, cauterizing,heating, freezing, lasing, dilating or otherwise modifying tissue suchas nasal polyps, abberant or enlarged tissue, abnormal tissue, etc.;grafting or implanting cells or tissue; reducing, setting, screwing,applying adhesive to, affixing, decompressing or otherwise treating afracture; delivering a gene or gene therapy preparation; removing all ora portion of a tumor; removing a polyp; delivering histamine, anallergen or another substance that causes secretion of mucous by tissueswithin a paranasal sinus to permit assessment of drainage from thesinus; implanting a cochlear implant or indwelling hearing aid oramplification device, etc.

Still further in accordance with the invention, there are provideddevices and systems for performing some or all of the proceduresdescribed herein. Introducing devices may be used to facilitateinsertion of working devices (e.g. catheters e.g. balloon catheters,tissue cutting or remodeling devices, guidewires, devices for implantingelements like stents, electrosurgical devices, energy emitting devices,devices for delivering diagnostic or therapeutic agents, substancedelivery implants, scopes etc) into the paranasal sinuses and otherstructures in the ear, nose or throat.

Still further in accordance with the invention, there are providedapparatus and methods for navigation and imaging of the interventionaldevices within the sinuses using endoscopic including stereo endoscopic,fluoroscopic, ultrasonic, radiofrequency localization, electromagnetic,magnetic and other radiative energy based modalities. These imaging andnavigation technologies may also be referenced by computer directly orindirectly to pre-existing or simultaneously created 3-D or 2-D datasets which help the doctor place the devices within the appropriateregion of the anatomy.

Further aspects, details and embodiments of the present invention willbe understood by those of skill in the art upon reading the followingdetailed description of the invention and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic diagram of a system for catheter-basedminimally invasive sinus surgery of the present invention being used toperform a sinus surgery procedure on a human patient.

FIG. 1A is an enlarged view of portion “1A” of FIG. 1.

FIGS. 2A through 2D are partial sagittal sectional views through a humanhead showing various steps of a method for gaining access to a paranasalsinus using a guide and thereafter dilating or remodeling the ostialopening into the paranasal sinus.

FIGS. 2E through 2H are partial sagittal sectional views through a humanhead showing various steps of a method for gaining access to a paranasalsinus using a steerable guide.

FIGS. 2I through 2L are partial sagittal sectional views through a humanhead showing various steps of a method for gaining access to a paranasalsinus using an introducing device in the form of a guidewire with apreset shape.

FIGS. 2M through 2O are partial sagittal sectional views through a humanhead showing various steps of a method for gaining access to a paranasalsinus using a balloon catheter that has a guide protruding from itsdistal end.

FIGS. 2P through 2X are partial sagittal sectional views through a humanhead showing various steps of a method of accessing an ethmoid sinusthrough a natural or artificially created opening of the ethmoid sinus.

FIGS. 2Y through 2AC are partial coronal sectional views through a humanhead showing various steps of a method for treating a mucocele in afrontal sinus.

FIGS. 3A through 3C are partial coronal sectional views through a humanhead showing various steps of a method of accessing a paranasal sinusthrough an artificially created opening of the paranasal sinus.

FIG. 4A shows a partial longitudinal sectional view of a system fordilating a sinus ostium or other intranasal anatomical structure, suchsystem comprising three progressively larger dilators useable insequence.

FIGS. 4B through 4E show various steps of a method of dilating a nasalcavity using a working device comprising a balloon catheter with apressure-expandable stent.

FIG. 4F shows a partial perspective view of a working device thatcomprises a side suction and/or side cutter.

FIG. 4G shows a partial perspective view of a working device thatcomprises a rotating cutter to cut away tissue.

FIGS. 4H and 4I show various steps of a method of dilating the ostium ofa paranasal sinus or other nasal passageway using a mechanical dilator.

FIGS. 4J and 4K show perspective views of a mechanical dilatorcomprising a screw mechanism.

FIGS. 4L and 4M show sectional views of a mechanical dilator thatcomprises a pushable member.

FIGS. 4N and 4O show sectional views of a mechanical dilator thatcomprises a pullable member.

FIGS. 4P and 4Q show sectional views of a mechanical dilator thatcomprises a hinged member.

FIGS. 4R through 4W are schematic diagrams of alternative configurationsfor the distal portions of mechanical dilators of the types shown inFIGS. 4H through 4Q.

FIG. 4S′ shows a partial perspective view of the outer stationary memberof FIG. 4R.

FIG. 4U′ shows a partial perspective view of the outer hemi-tubularmember of FIG. 4T.

FIG. 4W′ shows a partial perspective view of the outer curved member ofFIG. 4V.

FIG. 5A shows a perspective view of a balloon that comprises a conicalproximal portion, a conical distal portion and a cylindrical portionbetween the conical proximal portion and the conical distal portion.

FIG. 5B shows a perspective view of a conical balloon.

FIG. 5C shows a perspective view of a spherical balloon.

FIG. 5D shows a perspective view of a conical/square long balloon.

FIG. 5E shows a perspective view of a long spherical balloon.

FIG. 5F shows a perspective view of a bi-lobed “dog bone” balloon.

FIG. 5G shows a perspective view of an offset balloon.

FIG. 5H shows a perspective view of a square balloon.

FIG. 5I shows a perspective view of a conical/square balloon.

FIG. 5J shows a perspective view of a conical/spherical long balloon.

FIG. 5K shows a perspective view of an embodiment of a tapered balloon.

FIG. 5L shows a perspective view of a stepped balloon.

FIG. 5M shows a perspective view of a conical/offset balloon.

FIG. 5N shows a perspective view of a curved balloon.

FIG. 5O shows a partial perspective view of a balloon catheter devicecomprising a balloon for delivering diagnostic or therapeuticsubstances.

FIG. 5P shows a partial perspective view of a balloon/cutter catheterdevice comprising a balloon with one or more cutter blades.

FIG. 5Q shows a perspective view of a balloon catheter device comprisinga balloon with a reinforcing braid attached on the external surface ofthe balloon.

FIG. 5R shows a partial sectional view of a balloon catheter whereininflation ports are located near the distal end of the balloon.

FIG. 5S shows a partial sectional view of an embodiment of a ballooncatheter comprising multiple balloons inflated by a single lumen.

FIG. 5T shows a partial sectional view of a balloon catheter comprisingmultiple balloons inflated by multiple lumens.

FIGS. 5U through 5AB show perspective and sectional views of variousembodiments of balloon catheters having sensors mounted thereon ortherein.

FIG. 6A shows a partial perspective view of a shaft design useable inthe various devices disclosed herein, wherein the shaft comprises anexternal spiral wire.

FIG. 6B shows a partial perspective view of a shaft design for thevarious devices disclosed herein, wherein the shaft comprises astiffening wire.

FIG. 6C shows a partial perspective view of an embodiment of a shaftdesign for the various devices disclosed herein, wherein the shaftcomprises stiffening rings.

FIG. 6D shows a partial perspective view of a shaft design for thevarious devices disclosed herein, wherein the shaft comprisescontrollable stiffening elements.

FIG. 6E shows a partial perspective view of a shaft design for thevarious devices disclosed herein, wherein the shaft comprises ahypotube.

FIG. 6F shows a partial perspective cut-away view of a shaft design forthe various devices disclosed herein, wherein the shaft comprises abraid.

FIG. 6F′ is an enlarged side view of the braid of the device of FIG. 6F.

FIG. 6G shows a partial perspective view of an embodiment of a devicecomprising a shaft having a plastically deformable region.

FIG. 6H shows a partial perspective view of a device comprising a shafthaving a flexible element.

FIG. 6I shows a partial perspective view of a shaft comprising amalleable element.

FIG. 6J shows a partial perspective view of the shaft of FIG. 6I in abent configuration.

FIG. 6K shows a cross sectional view through plane 6K-6K of FIG. 6I.

FIG. 6L shows a partial sectional view of an embodiment of acontrollably deformable shaft.

FIG. 6M shows a partial sectional view of the controllably deformableshaft of FIG. 6L in a deformed state.

FIG. 6N shows a perspective view of a balloon catheter comprising arigid or semi-rigid member.

FIGS. 6O through 6Q show sectional views of a balloon catheter thatcomprises an insertable and removable element.

FIG. 7A shows a cross sectional view through a balloon catheter shaftcomprising two cylindrical lumens.

FIG. 7B shows a cross sectional view through a balloon catheter shaftcomprising an inner lumen and an annular outer lumen disposed about theinner lumen.

FIG. 7C shows a cross sectional view through a balloon catheter shaftwhich comprises a first tubular element with a first lumen, a secondtubular element with a second lumen and a jacket surrounding the firstand second tubular elements.

FIG. 7D shows a cross sectional view through a balloon catheter shaftcomprising three lumens.

FIG. 7E shows a cross sectional view through a balloon catheter shaftcomprising a cylindrical element, a tubular element that has a lumen anda jacket surrounding the cylindrical element and the tubular element.

FIG. 7F shows a cross sectional view through a balloon catheter shaftcomprising an embedded braid.

FIG. 7G shows a partial perspective view of a catheter shaft comprisinga zipper lumen with a guide extending through a portion of the zipperlumen.

FIG. 7H shows a cross sectional view through line 7H-7H of FIG. 7G.

FIG. 7I shows a partial longitudinal sectional view of a catheter shaftcomprising a rapid exchange lumen with a guide extending through therapid exchange lumen.

FIG. 7J shows a cross sectional view of the catheter shaft of FIG. 7Ithrough line 7J-7J.

FIG. 7K shows a cross sectional view of the catheter shaft of FIG. 7Ithrough line 7K-7K.

FIG. 7L is a partial perspective view of a balloon catheter device ofthe present invention comprising a through lumen and a balloon inflationlumen within the shaft of the catheter.

FIG. 7M is a cross sectional view through line 7M-7M of FIG. 7L.

FIG. 7N is a cross sectional view through line 7N-7N of FIG. 7L.

FIG. 7O is a partial perspective view of another balloon catheter deviceof the present invention comprising a through lumen within the shaft ofthe catheter and a balloon inflation tube disposed next to andoptionally attached to the catheter shaft.

FIG. 7P is a cross sectional view through line 7P-7P of FIG. 7O.

FIG. 7Q is a cross sectional view through line 7O-7O of FIG. 7.

FIG. 8A shows a partial perspective view of a catheter shaft comprisingdistance markers.

FIG. 8B shows a partial perspective view of a catheter shaft comprisingone type of radiopaque markers.

FIG. 8C shows a partial perspective view of a catheter shaft comprisinganother type of radiopaque markers.

FIG. 8D shows a partial perspective view of a balloon cathetercomprising an array of radiopaque markers arranged on the outer surfaceof the balloon.

FIG. 8E shows a partial perspective view of a balloon cathetercomprising an array of radiopaque markers arranged on an inner surfaceof the balloon.

FIG. 8E′ is a longitudinal sectional view of FIG. 8E.

DETAILED DESCRIPTION

The following detailed description, the accompanying drawings and theabove-set-forth Brief Description of the Drawings are intended todescribe some, but not necessarily all, examples or embodiments of theinvention. The contents of this detailed description do not limit thescope of the invention in any way.

A number of the drawings in this patent application show anatomicalstructures of the ear, nose and throat. In general, these anatomicalstructures are labeled with the following reference letters:

Nasal Cavity NC Nasopharynx NP Frontal Sinus FS Ethmoid Sinus ES EthmoidAir Cells EAC Sphenoid Sinus SS Sphenoid Sinus Ostium SSO MaxillarySinus MS Mucocele MC

FIGS. 1 and 1A provide a general showing of a minimally invasive surgerysystem of the present invention comprising a C-arm fluoroscope 1000 thatis useable to visualize a first introducing device 1002 (e.g., a guidecatheter or guide tube), a second introducing device 1004 (e.g., aguidewire or elongate probe) and a working device 1006 (e.g., a ballooncatheter, other dilation catheter, debrider, cutter, etc.). FIGS. 2A-8E′show certain non-limiting examples of the introducing devices 1002(e.g., a guide catheter or guide tube), 1004 (guides, guidewires,elongate probes, etc.) and working devices 1006 (e.g., a ballooncatheters, other dilation catheters, debrider, cutters, etc.) that maybe useable in accordance with this invention. The devices 1002, 1004,1006 may be radiopaque and/or may incorporate radiopaque markers suchthat C-arm fluoroscope 1000 may be used to image and monitor thepositioning of the devices 1002, 1004, 1006 during the procedure. Inaddition to or, as an alternative to the use of radiographic imaging,the devices 1002, 1004, 1006 may incorporate and/or may be used inconjunction with one or more endoscopic devices, such as the typicalrigid or flexible endoscopes or stereo endoscopes used byotolaryngologists during FESS procedures. Also, in addition to or as analternative to radiographic imaging and/or endoscopic visualizations,some embodiments of the devices 1002, 1004, 1006 may incorporate sensorswhich enable the devices 1002, 1004, 1006 to be used in conjunction withimage guided surgery systems or other electro-anatomicalmapping/guidance systems including but not limited to: VectorVision(BrainLAB AG); HipNav (CASurgica); CBYON Suite (CBYON); InstaTrak,FluoroTrak, ENTrak (GE Medical); StealthStation Treon, iOn (Medtronic);Medivision; Navitrack (Orthosoft); OTS (Radionics); VISLAN (Siemens);Stryker Navigation System (Stryker Leibinger); Voyager, Z-Box (Z-KatInc.) and NOGA and CARTO systems (Johnson & Johnson). Commerciallyavailable interventional navigation systems can also be used inconjunction with the devices and methods. Further non-fluoroscopicinterventional imaging technologies including but not limited to:OrthoPilot (B. Braun Aesculap); PoleStar (Odin Medical Technologies;marketed by Medtronic); SonoDoppler, SonoWand (MISON); CT Guide, USGuide (UltraGuide) etc. may also be used in conjunction with the devicesand methods. Guidance under magnetic resonance is also feasible if thecatheter is modified to interact with the system appropriately.

It is to be appreciated that the devices and methods of the presentinvention relate to the accessing and dilation or modification of sinusostia or other passageways within the ear nose and throat. These devicesand methods may be used alone or may be used in conjunction with othersurgical or non-surgical treatments, including but not limited to thedelivery or implantation of devices and drugs or other substances asdescribed in copending U.S. patent application Ser. No. 10/912,578entitled Implantable Devices and Methods for Delivering Drugs and OtherSubstances to Treat Sinusitis and Other Disorders filed on Aug. 4, 2004,issued as U.S. Pat. No. 7,361,168 on Apr. 22, 2008, the entiredisclosure of which is expressly incorporated herein by reference.

FIGS. 2A through 2D are partial sagittal sectional views through a humanhead showing various steps of a method of gaining access to a paranasalsinus using a guide catheter. In FIG. 2A, a first introducing device inthe form of a guide catheter 200 is introduced through a nostril andthrough a nasal cavity NC to a location close to an ostium SSO of asphenoid sinus SS. The guide catheter 200 may be flexible. Flexibledevices are defined as devices with a flexural stiffness less than about200 pound-force per inch over a device length of one inch. The guidecatheter 200 may be straight or it may incorporate one or more preformedcurves or bends. In embodiments where the guide catheter 200 is curvedor bent, the deflection angle of the curve or bend may be in the rangeof up to 135°. Examples of specific deflection angles formed by thecurved or bent regions of the guide catheter 200 are 0°, 30°, 45°, 60°,70°, 90°, 120° and 135°. Guide catheter 200 can be constructed fromsuitable elements like Pebax, Polyimide, Braided Polyimide,Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metals like stainlesssteel and fluoropolymers like PTFE, PFA, FEP and EPTFE. Guide catheter200 can have a variety of surface coatings e.g. hydrophilic lubriciouscoatings, hydrophobic lubricious coatings, abrasion resisting coatings,puncture resisting coatings, electrically or thermal conductivecoatings, radiopaque coatings, echogenic coatings, thrombogenicityreducing coatings and coatings that release drugs. In FIG. 2B, a secondintroduction device comprising a guidewire 202 is introduced through thefirst introduction device (i.e., the guide catheter 200) so that theguidewire 202 enters the sphenoid sinus SS through the ostium SSO.Guidewire 202 may be constructed and coated as is common in the art ofcardiology. In FIG. 2C, a working device 204 for example a ballooncatheter is introduced over guidewire 202 into the sphenoid sinus SS.Thereafter, in FIG. 2D, the working device 204 is used to perform adiagnostic or therapeutic procedure. In this particular example, theprocedure is dilation of the sphenoid sinus ostium SSO, as is evidentfrom FIG. 2D. However, it will be appreciated that the present inventionmay also be used to dilate or modify any sinus ostium or other man-madeor naturally occurring anatomical opening or passageway within the nose,paranasal sinuses, nasopharynx or adjacent areas. After the completionof the procedure, guide catheter 200, guidewire 202 and working device204 are withdrawn and removed. As will be appreciated by those of skillin the art, in this or any of the procedures described in this patentapplication, the operator may additionally advance other types ofcatheters or of the present invention, a guidewire 202 may be steerable(e.g. torquable, actively deformable) or shapeable or malleable.Guidewire 202 may comprise an embedded endoscope or other navigation orimaging modalities including but not limited to fluoroscopic, X-rayradiographic, ultrasonic, radiofrequency localization, electromagnetic,magnetic, robotic and other radiative energy based modalities. In thisregard, some of the figures show optional scopes SC is dotted lines. Itis to be appreciated that such optional scopes SC may comprise anysuitable types of rigid or flexible endoscopes and such optional scopesSC may be separate from or incorporated into the working devices and/orintroduction devices of the present invention.

FIGS. 2E through 2H are partial sagittal sectional views through a humanhead showing various steps of a method of gaining access to a paranasalsinus using a steerable catheter. In FIG. 2E, an introducing device inthe form of a steerable catheter 206 is introduced through a nostril.Although commercially available devices are neither designed, nor easilyusable for this technique in the sinuses, examples of a device which hasa steerable tip with functionality similar to that described hereinclude but are not limited to the Naviport™ manufactured by Cardima,Inc. in Fremont, Calif.; Attain Prevail and Attain Deflectable cathetersmanufactured by Medtronic; Livewire Steerable Catheters manufactured bySt. Jude Medical Inc.; Inquiry™ Steerable Diagnostic Cathetersmanufactured by Boston Scientific; TargetCath™ manufactured by EBI;Safe-Steer Catheter manufactured by Intraluminal Therapeutics, Inc.;Cynosar manufactured by Catheter Research, Inc.; Torque Control BalloonCatheter manufactured by Cordis Corp. and DynamicDeca Steerable Catheterand Dynamic XT Steerable Catheter manufactured by A.M.I. TechnologiesLtd, Israel. Steerable catheter 206 comprises a proximal portion, adistal portion and a controllably deformable region between the proximalportion and the distal portion. In FIG. 2F, the steerable catheter 206is steered through the nasal anatomy so that the distal portion ofsteerable catheter 206 is near an ostium SSO of a sphenoid sinus SS. InFIG. 2G, a working device in the form of a balloon catheter 208 isintroduced through steerable catheter 206 so that it enters sphenoidsinus SS through the ostium SSO. Thereafter, balloon catheter 208 isadjusted so that the balloon of the balloon catheter is located in theostium SSO. In FIG. 2H, balloon catheter 208 is used to dilate theostium SSO. After completion of the procedure, steerable catheter 206and balloon catheter 208 are withdrawn from the nasal anatomy. In thisexample, only a first introduction device in the form of a steerablecatheter 206 is used to effect insertion and operative positioning ofthe working device (which in this example is balloon catheter 208). Itwill be appreciated, however, in some procedures, a second introductiondevice (e.g., an elongate guide member, guidewire, elongate probe, etc.)could be advanced through the lumen of the steerable catheter 206 andthe working device 208 could then be advanced over such secondintroduction device to the desired operative location.

FIGS. 2I through 2L are partial sagittal sectional views through a humanhead showing various steps of a method for gaining access to a paranasalsinus using an introducing device in the form of a guidewire with apreset shape. In FIG. 2I, an introducing device in the form of aguidewire 210 with a preset shape is introduced in a nasal cavity.Guidewire 210 comprises a proximal portion and a distal portion and isshaped such that it can easily navigate through the nasal anatomy. Inone embodiment, guidewire 210 is substantially straight. In anotherembodiment, guidewire 210 comprises an angled, curved or bent regionbetween the proximal portion and the distal portion. Examples of thedeflection angle of the angled, curved or bent regions are 0°, 30°, 45°,60°, 70°, 90°, 120° and 135°. In FIG. 2J, guidewire 210 is advancedthrough the nasal anatomy so that the distal tip of guidewire enters asphenoid sinus SS through an ostium SSO. In FIG. 2K, a working device inthe form of a balloon catheter 212 is advanced along guidewire 210 intothe sphenoid sinus SS. Typically, as described more fully herebelow, theworking device will have a guidewire lumen extending through or formedin or on at least a portion of the working device 212 to facilitateadvancement of the working device 212 over the guidewire 212 in themanner well understood in the art of interventional medicine.Thereafter, the position of balloon catheter 212 is adjusted so that theballoon of the balloon catheter is located in the ostium SSO. Asdescribed elsewhere in this application, the balloon catheter 212 may beradiopaque and/or may incorporate one or more visible or imageablemarkers or sensors. In FIG. 2L, balloon catheter 212 is used to dilatethe ostium SSO. After completion of the procedure, guidewire 210 andballoon catheter 212 are withdrawn from the nasal anatomy. In oneembodiment, balloon catheter 212 is shapeable or malleable.

FIGS. 2M through 2O are partial sagittal sectional views through a humanhead showing various steps of a method of gaining access to a paranasalsinus using a balloon catheter comprising a steering wire at its distalend. In FIG. 2M, a working device comprising a balloon catheter 214comprising a proximal portion and distal portion is introduced in anasal cavity. Balloon catheter 214 comprises a steering wire 216 at itsdistal end. In FIG. 2N, balloon catheter 214 is advanced through thenasal anatomy into a sphenoid sinus SS through a sphenoid sinus ostiumSSO. Thereafter, the position of balloon catheter 214 is adjusted sothat the balloon of the balloon catheter is located in the ostium SSO.In FIG. 2O, balloon catheter 214 is used to dilate the ostium SSO. Aftercompletion of the procedure, balloon catheter 214 is withdrawn from thenasal anatomy. In one embodiment, steering wire 216 can be retractedinto or advanced from balloon catheter 214. The retraction oradvancement of steering wire can be controlled by several means like athumb wheel, a slide, a button hooked up to electronic motor and atrigger. In another embodiment, steering wire 216 may be hollow or mayincorporate one or more lumen(s) to enable it to introduce or removedevices or diagnostic or therapeutic agents, examples of which aredescribed in copending U.S. patent application Ser. No. 10/912,578entitled Implantable Devices and Methods for Delivering Drugs and OtherSubstances to Treat Sinusitis and Other Disorders filed on Aug. 4, 2004,issued as U.S. Pat. No. 7,361,168 on Apr. 22, 2008, the entiredisclosure of which is expressly incorporated herein by reference.

FIGS. 2P through 2X are partial sagittal sectional views through a humanhead showing various steps of a method for accessing an ethmoid sinusthrough a natural or artificially created opening of the ethmoid sinus.In FIG. 2P, an introducing device in the form of a guide catheter 218 isintroduced in an ethmoid sinus ES. Ethmoid sinus ES comprises multipleethmoid air cells EAC. In FIG. 2Q, a guidewire 220 is introduced throughguide catheter into a first EAC. Thereafter, in FIG. 2R, a ballooncatheter 222 is introduced over guidewire 220 into the first EAC. InFIG. 2S, balloon catheter 222 is inflated to dilate the structures ofES. In FIG. 2T, guide catheter 218, guidewire 220 and balloon catheter222 are withdrawn leaving a first new passage in the ES. The newlycreated passage in the ES facilitates drainage of the mucous through theES. Alternatively, in FIG. 2U, only balloon catheter 222 is withdrawn.The position of guide catheter 218 is adjusted and guidewire 220 isintroduced into a second EAC. In FIG. 2V, balloon catheter 222 isintroduced over guidewire 220 into the second EAC. In FIG. 2W, ballooncatheter 222 is inflated to dilate the structures of ES. In FIG. 2X,guide catheter 218, guidewire 220 and balloon catheter 222 are withdrawnleaving a second new passage in the ES. The second new passage in the ESfurther facilitates drainage of the mucous through the ES. This methodof dilating the structures of ES can be repeated to create multiple newpassages in the ES.

FIGS. 2Y through 2AC are partial coronal sectional views through a humanhead showing various steps of a method for treating a mucocele in afrontal sinus. In FIG. 2Y, an introducing device in the form of a guidecatheter 224 is introduced in a frontal sinus FS through the nasalcavity NC. Frontal sinus FS has a mucocele MC to be treated. In FIG. 2Z,a penetrating device 226 comprising a sharp tip 228 is introducedthrough guide catheter 224 such that penetrating device 226 puncturesthe MC at least partially. In FIG. 2AA, a balloon catheter 230 isintroduced over penetrating device 226 into the MC. Thereafter, in FIG.2AB, balloon catheter 230 is inflated to rupture the MC and allow thedrainage of contents of the MC. In FIG. 2AC, penetrating device 226 andballoon catheter 230 are withdrawn.

The methods disclosed herein may also comprise the step of cleaning orlavaging anatomy within the nose, paranasal sinus, nasopharynx or nearbystructures including but not limited to irrigating and suctioning. Thestep of cleaning the target anatomy can be performed before or after adiagnostic or therapeutic procedure.

The methods of the present invention may also include one or morepreparatory steps for preparing the nose, paranasal sinus, nasopharynxor nearby structures for the procedure, such as spraying or lavagingwith a vasoconstricting agent (e.g., 0.025-0.5% phenylephyrine orOxymetazoline hydrochloride (Neosynephrine or Afrin) to cause shrinkageof the nasal tissues, an antibacterial agent (e.g., provodine iodine(Betadine), etc. to cleanse the tissues, etc.

FIGS. 3A through 3C are partial coronal sectional views through a humanhead showing various steps of a method of accessing a paranasal sinusthrough an artificially created opening of the paranasal sinus. In FIG.3A, a puncturing device 300 is inserted through a nostril and used tocreate an artificial opening in a maxillary sinus. There are severalpuncturing devices well known in the art like needles including needles,needles with bent shafts, dissectors, punches, drills, corers, scalpels,burs, scissors, forceps and cutters. In FIG. 3B, puncturing device 300is withdrawn and a working device for example a balloon catheter 302 isintroduced through the artificial opening into the maxillary sinus. InFIG. 3C, balloon catheter 302 is used to dilate the artificially createdopening in the maxillary sinus. After this step, the balloon catheter302 is withdrawn. It will be appreciated that, in some embodiments, thepuncturing device 300 may have a lumen through which an introductiondevice (e.g., a guidewire or other elongate probe or member), may beinserted into the maxillary sinus and the puncturing device 300 may thenbe removed leaving such introduction device (e.g., a guidewire or otherelongate probe or member) in place. In such cases, the working device(e.g., balloon catheter 302) may incorporate a lumen or other structurethat allows the working device (e.g., balloon catheter 300) to beadvanced over the previously inserted introduction device (e.g., aguidewire or other elongate probe or member).

In the methods illustrated so far, balloon catheters were used only asan example for the several alternate working devices that could be usedwith this invention. FIG. 4A shows a sectional view of an example of aworking device comprising a set of three sequential dilators: a firstsequential dilator 402, a second sequential dilator 404 and a thirdsequential dilator 406. The D3 of third sequential dilator 406 isgreater than the diameter D2 of second sequential dilator 404 which inturn is greater than the diameter D1 of first sequential dilator 402.The sequential dilators may comprise one or more bent or angled regions.The sequential dilators can be constructed from a variety ofbiocompatible materials like stainless steel 316. A variety of othermetals, polymers and materials can also be used to construct thesequential dilators.

FIGS. 4B through 4E show various steps of a method of dilating a nasalcavity using a working device comprising a balloon catheter with apressure-expandable stent. In FIG. 4B, an introducing device e.g. aguidewire 416 is introduced into a nasal cavity e.g. an ostium of asinus. In FIG. 4C, a balloon catheter 418 is introduced over guidewire416 into the nasal cavity. Balloon catheter 418 comprises apressure-expandable stent 420. The position of balloon catheter 418 isadjusted so that pressure-expandable stent 420 is located substantiallywithin the target anatomy where the stent is to be deployed. In FIG. 4D,the balloon of balloon catheter 418 is expanded to deploypressure-expandable stent 420. In FIG. 4E, balloon catheter 418 iswithdrawn leaving pressure-expandable stent 420 in the nasal cavity.Several types of stent designs can be used to construct stent 420 likemetallic tube designs, polymeric tube designs, chain-linked designs,spiral designs, rolled sheet designs, single wire designs etc. Thesedesigns may have an open celled or closed celled structure. A variety offabrication methods can be used for fabricating stent 420 including butnot limited to laser cutting a metal or polymer element, welding metalelements etc. A variety of materials can be used for fabricating stent420 including but not limited to metals, polymers, foam type materials,plastically deformable materials, super elastic materials etc. Somenon-limiting examples of materials that can be used to construct thestent are silicones e.g. silastic, polyurethane, gelfilm andpolyethylene. A variety of features can be added to stent 420 includingbut not limited to radiopaque coatings, drug elution mechanisms etc.

FIG. 4F shows a partial perspective view of an embodiment of a workingdevice comprising a side suction and/or cutting device 422 comprising adevice body 424 having a side opening 426. Cutting device 422 isadvanced into a passageway such as a nostril, nasal cavity, meatus,ostium, interior of a sinus, etc. and positioned so that side opening426 is adjacent to matter (e.g., a polyp, lesion, piece of debris,tissue, blood clot, etc.) that is to be removed. Cutting device 422 isrotated to cut tissue that has been positioned in the side opening 426.Cutting device 422 may incorporate a deflectable tip or a curved distalend which may force side opening 426 against the tissue of interest.Further, this cutting device 422 may have an optional stabilizingballoon incorporated on one side of cutting device 422 to press itagainst the tissue of interest and may also contain one or more on-boardimaging modalities such as ultrasound, fiber or digital optics, OCT, RFor electro-magnetic sensors or emitters, etc.

FIG. 4G shows a partial perspective view of an embodiment of a workingdevice comprising a rotating cutter device to cut away tissue. Rotatingcutter device 428 comprises a rotating member 430 enclosed in anintroducing device 432. Rotating member 430 comprises a rotating blade434 located near the distal region of rotating member 430. Rotatingblade 434 may be retractable into rotating member 430. Rotating cutterdevice 428 is inserted in a passageway 436 such as a nostril, nasalcavity, meatus, ostium, interior of a sinus, etc. and positioned so thatrotating blade 434 is adjacent to matter (e.g., a polyp, lesion, pieceof debris, tissue, blood clot, etc.) that is to be removed. Thereafter,rotating member 430 is rotated to cause rotating blade 434 to removetissue. In one embodiment, rotating member 430 can be retracted intointroducing device 432. In another embodiment, rotating cutter device428 may comprise a mechanism for suction or irrigation near the distalend of rotating cutter device 428.

FIGS. 4H and 4I show various steps of a method of dilating a nasalcavity using a working device comprising a mechanical dilator 408.Mechanical dilator 408 comprises an outer member 410, an inner member412 and one or more elongate bendable members 414. Inner member 412 canslide within outer member 410. The proximal ends of bendable members 414are attached to distal end of outer member 410 and the distal ends ofbendable members 414 are attached to distal end of inner member 412. InFIG. 4H, mechanical dilator 408 is inserted into an opening in the nasalanatomy e.g. an ostium of a sinus. Mechanical dilator 408 is positionedin the opening such that bendable members 414 are within the opening inthe nasal anatomy. In FIG. 4I, relative motion of outer member 410 andinner member 412 causes the distal end of outer member 410 to comecloser to the distal end of inner member 412. This causes bendablemembers 414 to bend such that the diameter of the distal region ofmechanical dilator 408 increases. This causes bendable members 414 tocome into contact with the opening in the nasal anatomy and exert anoutward pressure to dilate the opening. Various components of mechanicaldilator 408 like outer member 410, inner member 412 and bendable members414 can be constructed from suitable biocompatible materials likestainless steel 316. A variety of other metals, polymers and materialscan also be used to construct the various components of mechanicaldilator 408. In one embodiment, outer member 410 is substantially rigidand inner member 412 is flexible. Outer member 410 can be substantiallystraight or may comprise one or more bent or angled regions. Innermember 412 may comprise one or more lumens.

FIGS. 4J and 4K illustrate a perspective view of a design of amechanical dilator comprising a screw mechanism. FIG. 4J shows themechanical dilator comprising an outer member 438 and an inner screwmember 440. Inner screw member 440 is connected to outer member 438through a first pivot 442 located on the distal end of outer member 438.The distal end of inner screw member 440 is connected to a second pivot444. The mechanical dilator further comprises one or more bendablemembers 446. The distal end of bendable members 446 is attached tosecond pivot 444 and the proximal end of bendable members 446 isattached to first pivot 442. In FIG. 4K, inner screw member 440 isrotated in one direction. This causes second pivot 444 to come closer tofirst pivot 442. This causes bendable members 446 to bend in the radialdirection exerting an outward radial force. This force can be used todilate or displace portions of the anatomy. Outer member 438 can besubstantially straight or may comprise one or more bent or angledregions. Inner screw member 440 may comprise one or more lumens.

FIGS. 4L and 4M illustrate sectional views of a design of a mechanicaldilator comprising a pushable member. FIG. 4L shows the mechanicaldilator comprising an outer member 448 comprising one or more bendableregions 449 on the distal end of outer member 448. Mechanical dilatorfurther comprises an inner pushable member 450 comprising an enlargedregion 452 on the distal end of inner pushable member 450. In FIG. 4M,inner pushable member 450 is pushed in the distal direction. This exertsan outward force on bendable regions 449 causing bendable regions 449 tobend in a radial direction exerting an outward force. This force can beused to dilate or displace portions of the anatomy. Outer member 448 canbe substantially straight or may comprise one or more bent or angledregions. Inner pushable member 450 may comprise one or more lumens.

FIGS. 4N and 4O illustrate sectional views of a design of a mechanicaldilator comprising a pullable member. FIG. 4N shows the mechanicaldilator comprising an outer member 454 comprising one or more bendableregions 456 on the distal end of outer member 454. Mechanical dilatorfurther comprises an inner pullable member 458 comprising an enlargedregion 460 on the distal end of inner pullable member 458. In FIG. 4O,inner pullable member 458 is pulled in the proximal direction. Thisexerts an outward force on bendable regions 456 causing bendable regions456 to bend in a radial direction exerting an outward force. This forcecan be used to dilate or displace portions of the anatomy. Outer member454 can be substantially straight or may comprise one or more bent orangled regions. Inner pullable member 458 may comprise one or morelumens.

FIGS. 4P and 4Q illustrate sectional views of a design of a mechanicaldilator comprising a hinged member. FIG. 4P shows the mechanical dilatorcomprising an outer member 462 comprising one or more bendable regions464 located on the distal end of outer member 462. The mechanicaldilator also comprises an inner member 466 located within outer member462. In one embodiment, inner member 466 is tubular. The distal end ofinner member 466 comprises one or more first hinges 468. First hinges468 are hinged to the proximal ends of one or more moving elements 470.Distal ends of moving elements 470 are hinged to one or more secondhinges 472 located on the inner surface of outer member 462. In FIG. 4Q,inner member 466 is pushed in the distal direction. This causes movingelements 470 to exert an outward radial force on bendable regions 464causing bendable regions 464 to bend in an outward radial direction withan outward force. This outward force can be used to dilate or displaceportions of the anatomy. Outer member 462 can be substantially straightor may comprise one or more bent or angled regions. Inner member 466 maycomprise one or more lumens.

FIGS. 4R through 4W illustrate examples of configurations of mechanicaldilators in FIGS. 4H through 4Q. FIG. 4R shows a sectional view of amechanical dilator comprising an inner member 474, an outer stationarymember 476 and an outer bendable member 478. In FIG. 4S, movement ofinner member 474 displaces outer bendable member 478 in the radialdirection with a force. This force can be used to dilate or displaceportions of the anatomy. This configuration is useful to exert force ina particular radial direction. FIG. 4S′ shows a partial perspective viewof the outer stationary member 476 of FIG. 4R. FIG. 4T shows a sectionalview of a mechanical dilator comprising an inner member 480, a firstouter hemi-tubular member 482 and a second outer hemi-tubular member484. In FIG. 4U, movement of inner member 480 displaces first outerhemi-tubular member 482 and second outer hemi-tubular member 484 in theradial direction with a force. This force can be used to dilate ordisplace portions of the anatomy. This configuration is useful to exertforce in two diametrically opposite regions. FIG. 4U′ shows a partialperspective view of the first outer hemi-tubular member 482 and thesecond outer hemi-tubular member 484 of FIG. 4T. FIG. 4V shows asectional view of a mechanical dilator comprising an inner member 486, afirst outer curved member 488 and a second outer curved member 490. InFIG. 4W, movement of inner member 486 displaces first outer curvedmember 488 and second outer curved member 490 in the radial directionwith a force. This force can be used to dilate or displace portions ofthe anatomy. This configuration is useful to exert force over smallerareas in two diametrically opposite regions. FIG. 4W′ shows a partialperspective view of the first outer curved member 488 and the secondouter curved member 490 of FIG. 4V. Similar designs for mechanicaldilators in FIGS. 4H through 4Q are possible using three or moredisplaceable members. The inner member in the mechanical dilatorsdisclosed herein may be replaced by a balloon for displacing the outermembers to exert an outward radial force.

Several other designs of the working device may also be used includingbut not limited to cutters, chompers, rotating drills, rotating blades,tapered dilators, punches, dissectors, burs, non-inflating mechanicallyexpandable members, high frequency mechanical vibrators, radiofrequencyablation devices, microwave ablation devices, laser devices (e.g. CO2,Argon, potassium titanyl phosphate, Holmium:YAG and Nd:YAG laserdevices), snares, biopsy tools, scopes and devices that introducediagnostic or therapeutic agents.

FIG. 5A shows a perspective view of an embodiment of a ballooncomprising a conical proximal portion, a conical distal portion and acylindrical portion between the conical proximal portion and the conicaldistal portion. FIGS. 5B to 5N show perspective views of severalalternate embodiments of the balloon. FIG. 5B shows a conical balloon,FIG. 5C shows a spherical balloon, FIG. 5D shows a conical/square longballoon, FIG. 5E shows a long spherical balloon, FIG. 5F shows a dogbone balloon, FIG. 5G shows a offset balloon, FIG. 5H shows a squareballoon, FIG. 5I shows a conical/square balloon, FIG. 5J shows aconical/spherical long balloon, FIG. 5K shows a tapered balloon, FIG. 5Lshows a stepped balloon, FIG. 5M shows a conical/offset balloon and FIG.5N shows a curved balloon.

The balloons disclosed herein can be fabricated from biocompatiblematerials including but not limited to polyethylene terephthalate,Nylon, polyurethane, polyvinyl chloride, crosslinked polyethylene,polyolefins, HPTFE, HPE, HDPE, LDPE, EPTFE, block copolymers, latex andsilicone. The balloons disclosed herein can be fabricated by a varietyof fabrication methods including but not limited to molding, blowmolding, dipping, extruding etc.

The balloons disclosed herein can be inflated with a variety ofinflation media including but not limited to saline, water, air,radiographic contrast materials, diagnostic or therapeutic substances,ultrasound echogenic materials and fluids that conduct heat, cold orelectricity.

The balloons in this invention can also be modified to deliverdiagnostic or therapeutic substances to the target anatomy. For example,FIG. 5O shows a partial perspective view of an embodiment of a ballooncatheter device 500 comprising a balloon for delivering diagnostic ortherapeutic substances. Balloon catheter device 500 comprises a flexiblecatheter 502 having a balloon 504 thereon. The catheter device 500 isadvanced, with balloon 504 deflated, into a passageway such as anostril, nasal cavity, meatus, ostium, interior of a sinus, etc. andpositioned with the deflated balloon 504 situated within an ostium,passageway or adjacent to tissue or matter that is to be dilated,expanded or compressed (e.g., to apply pressure for hemostasis, etc.).Thereafter, the balloon 504 may be inflated to dilate, expand orcompress the ostium, passageway, tissue or matter. Thereafter theballoon 504 may be deflated and the device 500 may be removed. Thisballoon 504 may also be coated, impregnated or otherwise provided with amedicament or substance that will elute from the balloon into theadjacent tissue (e.g., bathing the adjacent tissue with drug orradiating the tissue with thermal or other energy to shrink the tissuesin contact with the balloon 504). Alternatively, in some embodiments,the balloon may have a plurality of apertures or openings through whicha substance may be delivered, sometimes under pressure, to cause thesubstance to bathe or diffuse into the tissues adjacent to the balloon.Alternatively, in some embodiments, radioactive seeds, threads, ribbons,gas or liquid, etc. may be advanced into the catheter shaft 502 orballoon 504 or a completely separate catheter body for some period oftime to expose the adjacent tissue and to achieve a desired diagnosticor therapeutic effect (e.g. tissue shrinkage, etc.).

The balloons in this invention can have a variety of surface features toenhance the diagnostic or therapeutic effects of a procedure. Forexample, FIG. 5P shows a partial perspective view of an embodiment of aballoon/cutter catheter device 506 comprising a flexible catheter 508having a balloon 510 with one or more cutter blades 512 formed thereon.The device 506 is advanced, with balloon 510 deflated, into a passagewaysuch as a nostril, nasal cavity, meatus, ostium, interior of a sinus,etc. and positioned with the deflated balloon 510 situated within anostium, passageway or adjacent to tissue or matter that is to bedilated, expanded or compressed and in which it is desired to make oneor more cuts or scores (e.g. to control the fracturing of tissue duringexpansion and minimize tissue trauma etc.). Thereafter, the balloon 510is inflated to dilate, expand or compress the ostium, passageway, tissueor matter and causing the cutter blade(s) 512 to make cut(s) in theadjacent tissue or matter. Thereafter the balloon 510 is deflated andthe device 506 is removed. The blade may be energized with mono orbi-polar RF energy or otherwise heated such that it will cut the tissueswhile also causing hemostasis and/or to cause thermal contraction ofcollagen fibers or other connective tissue proteins, remodeling orsoftening of cartilage, etc.

The balloons in this invention can have a variety of reinforcing meansto enhance the balloon properties. For example, FIGS. 5Q and 6F showperspective views of an embodiment of a balloon catheter device 514comprising a flexible catheter 516 having a balloon 518 with one or morereinforcing means 520 thereon. In this example, reinforcing means 520 isa braid attached on the external surface of balloon 518. The reinforcingbraid can be constructed from suitable materials like polymer filaments(e.g. PET or Kevlar filaments), metallic filaments (e.g. SS316 orNitinol filaments) and metallic or non-metallic meshes or sheets. Avariety of other reinforcing means can be used including but not limitedto reinforcing coatings, external or internal reinforcing coils,reinforcing fabric, reinforcing meshes and reinforcing wires,reinforcing rings, filaments embedded in balloon materials etc. FIG. 6F′shows a perspective view of a reinforcing braid that can be used withthe balloon catheter device in FIGS. 5Q and 6F.

The balloons in this invention can have a variety of inflation means toenhance the balloon properties. FIG. 5R shows a partial sectional viewof an embodiment of a balloon catheter 522 comprising a shaft 524 and aballoon 526. Shaft 524 comprises a balloon inflation lumen. The distalportion of balloon inflation lumen terminates in inflation ports 528located near the distal end of balloon 526. Thus, when balloon catheter522 is inserted in an orifice and balloon 526 is inflated, the distalportion of balloon 526 inflates earlier than the proximal portion ofballoon 526. This prevents balloon 526 from slipping back out of theorifice.

FIGS. 5S through 5T illustrate designs of balloon catheters comprisingmultiple balloons. FIG. 5S shows a partial sectional view of anembodiment of a balloon catheter 530 comprising a shaft 532 with a lumen533. Lumen 533 opens into three orifices located on shaft 532 namely afirst orifice 534, a second orifice 536 and a third orifice 538. Thethree orifices are used to inflate three balloons. First orifice 534inflates a first balloon 540, second orifice 536 inflates a secondballoon 542 and third orifice 538 inflates third balloon 544. In oneembodiment, first balloon 540 and third balloon 544 are inflated with asingle lumen and second balloon 542 is inflated with a different lumen.In another embodiment, first balloon 540, second balloon 542 and thirdballoon 544 interconnected and are inflated with a single lumen. A valvemechanism allows first balloon and second balloon to inflate beforeallowing second balloon to inflate.

Alternatively, the balloons can be inflated by separate lumens. FIG. 5Tshows a partial sectional view of an embodiment of a balloon catheter546 comprising a shaft 548 comprising a first inflation lumen 550, asecond inflation lumen 552 and a third inflation lumen 554. The threeinflation lumens are used to inflate three non-connected balloons. Firstinflation lumen 550 inflates a first balloon 556, second inflation lumen552 inflates a second balloon 558 and third inflation lumen 554 inflatesa third balloon 560.

The devices disclosed herein may comprise one or more navigation orvisualization modalities. FIGS. 5U through 5AB illustrate perspectiveand sectional views of various embodiments of a balloon cathetercomprising sensors. FIG. 5U shows a partial perspective view of aballoon catheter comprising an outer member 562, an inner member 564 anda balloon 566 attached to distal region of outer member 562 and distalregion of inner member 564. The balloon catheter further comprises afirst sensor 568 located on the distal region of outer member 562 and asecond sensor 570 located on the distal region of inner member 564. FIG.5V shows a crossection through plane 5V-5V in FIG. 5U. Outer member 562comprises a first sensor lumen 572 to receive the lead from first sensor568. Inner member 564 comprises a second sensor lumen 574 to receive thelead from second sensor 570. Inner member 564 further comprises acircular lumen 576. Outer member 562 and inner member 564 enclose anannular lumen 578. In one embodiment, annular lumen 578 is a ballooninflation lumen.

FIG. 5W shows a partial perspective view of a balloon cathetercomprising an outer member 580, an inner member 582 and a balloon 584attached to distal region of outer member 580 and distal region of innermember 582. The balloon catheter further comprises a first sensor 586located on the distal region of inner member 582 and a second sensor 588located on the distal region of inner member 582 distal to first sensor586. FIG. 5X shows a cross section through plane 5X-5X in FIG. 5W. Innermember 582 comprises a first sensor lumen 590 to receive the lead fromfirst sensor 586 and a second sensor lumen 592 to receive the lead fromsecond sensor 588. Inner member 582 further comprises a circular lumen594. Outer member 580 and inner member 582 enclose an annular lumen 596.In one embodiment, annular lumen 596 is a balloon inflation lumen.

FIG. 5Y shows a partial perspective view of a balloon cathetercomprising an outer member 598, an inner member 600 and a balloon 602attached to distal region of outer member 598 and distal region of innermember 600. The balloon catheter further comprises a first sensor 604located on the distal region of outer member 598 and a second sensor 606located on the distal region of outer member 598 distal to first sensor604. FIG. 5Z shows a cross section through plane 5Z-5Z in FIG. 5Y. Outermember 598 comprises a first sensor lumen 608 to receive the lead fromfirst sensor 604 and a second sensor lumen 610 to receive the lead fromsecond sensor 606. Inner member 600 comprises a circular lumen 612.Outer member 598 and inner member 600 enclose an annular lumen 614. Inone embodiment, annular lumen 614 is a balloon inflation lumen.

The leads from the sensors may be attached on the surface of an elementof the balloon catheter without being enclosed in a lumen. FIG. 5AAshows a partial perspective view of a balloon catheter comprising anouter member 616, an inner member 618 and a balloon 620 attached todistal region of outer member 616 and distal region of inner member 618.The balloon catheter further comprises a first sensor 624 located on thedistal region of outer member 616 and a second sensor 626 located on thedistal region of inner member 618. Second sensor 626 comprises a lead628. FIG. 5AB shows a cross section through plane 5AB-5AB in FIG. 5AA.Outer member 616 comprises a first sensor lumen 630 to receive the leadfrom first sensor 624. Inner member 618 comprises a circular lumen 632.Lead 628 from second sensor 626 is attached on the outer surface ofinner member 618 and is oriented parallel to inner member 618. Outermember 616 and inner member 618 enclose an annular lumen 634. In oneembodiment, annular lumen 634 is a balloon inflation lumen. The sensorsmentioned in FIGS. 5U through 5AB can be electromagnetic sensors orsensors including but not limited to location sensors, magnetic sensors,electromagnetic coils, RF transmitters, mini-transponders, ultrasoundsensitive or emitting crystals, wire-matrices, micro-silicon chips,fiber-optic sensors, etc.

FIGS. 6A through 6G illustrate partial perspective views of severalembodiments of shaft designs for the various devices disclosed herein.These shaft designs are especially useful for devices that encounterhigh torque or high burst pressures or require enhanced pushability,steerability and kink resistance. FIG. 6A shows a partial perspectiveview of an embodiment of a shaft 602 comprising a spiral element 604wound around the shaft. Spiral element 604 can be made of suitablematerials like metals (e.g. SS316L, SS304) and polymers. In oneembodiment, spiral element 604 is in the form of round wire of diameterbetween 0.04 mm to 0.25 mm. In another embodiment, spiral element is inthe form of flat wire of cross section dimensions ranging from 0.03mm×0.08 mm to 0.08 mm×0.25 mm. FIG. 6B shows a partial perspective viewof an embodiment of a shaft 606 comprising a reinforcing filament 608.Reinforcing filament 608 is substantially parallel to the axis of shaft606. Shaft 606 with reinforcing filament 608 can be covered with ajacketing layer. Reinforcing filament 608 can be made of suitablematerials like metals, polymers, glass fiber etc. Reinforcing filament608 can also have shape memory characteristics. In one embodiment,reinforcing filament 608 is embedded in shaft 606. In anotherembodiment, reinforcing filament is introduced through a lumen in shaft606. Shaft 606 may comprise more than one reinforcing filament 608. FIG.6C shows a partial perspective view of an embodiment of a shaft 610comprising one of more stiffening rings 612 along the length of shaft610. FIG. 6D shows a partial perspective view of an embodiment of ashaft 614 comprising a series of controllably stiffening elements 616along the length of the shaft. Shaft 614 further comprises a tensionwire 618 that runs through controllably stiffening elements 616 and isattached to the most distal stiffening element. The tension in tensionwire 618 causes controllably stiffening elements 616 to come intocontact with each other with a force. Friction between controllablystiffening elements 616 causes shaft 614 to have a certain stiffness.Increasing the tension in tension wire 618 increases the force withwhich controllably stiffening elements 616 come into contact with eachother. This increases the friction between controllably stiffeningelements 616 which in turn increases the stiffness of shaft 614.Similarly, reducing the tension in tension wire 618 reduces thestiffness of shaft 614. Controllably stiffening elements 616 can be madefrom suitable materials like metal, polymers and composites. In oneembodiment, controllably stiffening elements 616 are separated from eachother by one or more springs. Tension wire 618 can be made from metalslike SS316. Tension wire 618 may also be used to cause the device toactively bend or shorten in response to tension. FIG. 6E shows a partialperspective view of an embodiment of a shaft 620 comprising a hypotube622. In one embodiment, hypotube 622 is located on the exterior surfaceof shaft 620. In another embodiment, hypotube 622 is embedded in shaft620. Hypotube 620 can be made of metals like stainless steel 316 orsuitable polymers. FIGS. 6F and 6F′ show a partial perspective view ofan embodiment of a shaft 624 comprising a reinforcing element 626 in theform of a reinforcing braid or mesh located on the outer surface ofshaft 624. Reinforcing element 626 can be made of suitable materialslike polymer filaments (e.g. PET or Kevlar filaments), metallic wirese.g. SS316 wires etc. The braid pattern can be regular braid pattern,diamond braid pattern, diamond braid pattern with a half load etc. Inone embodiment, the outer surface of reinforcing element 626 is coveredwith a jacketing layer.

The shafts of various devices disclosed herein may be non homogenousalong their length. Examples of such shafts are illustrated in FIGS. 6Gthrough 6H. FIG. 6G shows a partial perspective view of an embodiment ofa device comprising a shaft 628 comprising a proximal portion 630, adistal portion 632, a working element 634 and a plastically deformableregion 636 located between the proximal portion 630 and distal portion632. Plastically deformable region 636 can be deformed by a physician toadjust the angle between proximal portion 630 and distal portion 632.This enables the devices to be used for several different anatomicalregions of the same patient. Also, such devices can be adjusted foroptimal navigation through a patient's anatomy. In one embodiment, shaft628 comprises multiple plastically deformable regions. In anotherembodiment plastically deformable region 636 is located within workingelement 634. Such a design comprising one or more plastically deformableregions can be used for any of the devices mentioned herein likecatheters with working elements, guide catheters, guide catheters with apre-set shape, steerable guide catheters, steerable catheters,guidewires, guidewires with a pre-set shape, steerable guidewires,ports, introducers, sheaths etc.

FIG. 6H shows a partial perspective view of an embodiment of a devicecomprising a shaft with a flexible element. The design is illustrated asa shaft 638 comprising a proximal portion 640, a distal portion 642 anda working element 644 (e.g. a balloon). Shaft 638 further comprises aflexible element 646 located between proximal portion 640 and distalportion 642. This design enables proximal portion 640 to bend withrespect to distal portion 642 making it easier to navigate through thecomplex anatomy and deliver working element 644 to the desired location.In one embodiment, shaft 638 comprises multiple flexible elements. Inanother embodiment, flexible element 646 is located within workingelement 644. Such a design comprising one or more flexible elements canbe used for any of the devices mentioned herein like catheters withworking elements, guide catheters, guide catheters with a pre-set shape,steerable guide catheters, steerable catheters, guidewires, guidewireswith a pre-set shape, steerable guidewires, ports, introducers, sheathsetc.

FIGS. 6I through 6K illustrate an example of a shaft comprising amalleable element. FIG. 6I shows a partial perspective view of anembodiment of a shaft 648 comprising malleable element 650 and a lumen652 wherein shaft 648 is in a substantially straight configuration.Malleable element 650 is embedded in shaft 648 such that the axis ofmalleable element 650 is substantially parallel to the axis of shaft648. FIG. 6J shows a partial perspective view of the embodiment of FIG.6I in a bent configuration. FIG. 6K shows a cross sectional view throughplane 6K-6K of FIG. 6I showing shaft 648 comprising malleable element650 and a lumen 652. In one embodiment, shaft 648 comprises more thanone malleable element.

FIGS. 6L through 6M show an embodiment of a controllably deformableshaft. FIG. 6L shows a partial sectional view of an embodiment of acontrollably deformable shaft 654 comprising a pull wire 656 attached toa pull wire terminator 658 located near the distal end of shaft 654.FIG. 6M shows a partial sectional view of the controllably deformableshaft 654 of FIG. 6L in a bent orientation when pull wire 656 is pulledin the proximal direction. The deformation can be varied by varying thelocation of pull wire terminator 658 and the stiffness of varioussections of shaft 658. The stiffness of a section of shaft 658 can bevaried by adding reinforcing coatings, external or internal reinforcingcoils, reinforcing fabric, reinforcing meshes and reinforcing wires,hinged elements, embedded filaments, reinforcing rings etc.

FIG. 6N shows a perspective view of a balloon catheter comprising arigid or semirigid member. The balloon catheter comprises a rigid orsemi-rigid member 660 and a balloon 662 located on the distal region ofrigid or semi-rigid member 660. Rigid or semi-rigid member 660 maycomprise one or more lumens. Rigid or semi-rigid member 660 may compriseone or more bent, curved or angled regions. Balloon 662 is inflated by aballoon inflation tube 664 comprising a hub 666 at the proximal end ofballoon inflation tube 664. In one embodiment, balloon inflation tube664 is fully attached along its length to rigid or semi-rigid member660. In another embodiment, balloon inflation tube 664 is partiallyattached along its length to rigid or semi-rigid member 660.

FIGS. 6O through 6Q illustrate sectional views of a balloon cathetercomprising an insertable and removable element. FIG. 6O shows a ballooncatheter 668 comprising a balloon 670, a first lumen 672 and a ballooninflation lumen 674 opening into balloon 670 through an inflation port676. FIG. 6P shows an insertable element 678 having a proximal end 680and a distal end 682. In one embodiment, distal end 682 ends in a sharptip for penetrating tissue. In one embodiment, insertable element 678comprises one or more bent, angled or curved regions 684. Insertableelement 678 can be fabricated from a variety of materials to obtainproperties including but not limited to rigidity, shape memory,elasticity, ability to be plastically deformed etc. In FIG. 6Q,insertable element 678 is inserted into balloon catheter 668 throughfirst lumen 672. This combination can be used to perform a diagnostic ortherapeutic procedure. Insertable element 678 may be removed during orafter the procedure.

FIGS. 7A through 7K show cross sectional views of several embodiments oflumen orientation in the devices disclosed herein. FIG. 7A shows a crosssectional view of an embodiment of a shaft 702 comprising a first lumen704 and a second lumen 706. In one embodiment, first lumen 704 is aguidewire lumen and second lumen 706 is an inflation lumen. FIG. 7Bshows a cross sectional view of an embodiment of a shaft 708 comprisinga first lumen 710 and a annular second lumen 712 such that secondannular lumen 712 is substantially coaxial with first lumen 710. In oneembodiment, first lumen 710 is a guidewire lumen and annular secondlumen 712 is an inflation lumen. FIG. 7C shows a cross sectional view ofan embodiment of a shaft 714 comprising a first tubular element 716comprising a first lumen 718, a second tubular element 720 comprising asecond lumen 722 and a jacket 724 surrounding first tubular element 716and second tubular element 720. In one embodiment, first lumen 718 is aguidewire lumen and second lumen 722 is an inflation lumen. FIG. 7Dshows a cross sectional view of an embodiment of a shaft 726 comprisinga first lumen 728, a second lumen 730 and a third lumen 732. In oneembodiment, first lumen 728 is a guidewire lumen, second lumen 730 is anirrigation/aspiration lumen and third lumen 732 is an inflation lumen.FIG. 7E shows a cross sectional view of an embodiment of a shaft 734comprising a cylindrical element 736, a tubular element 738 comprising alumen 740 and a jacket 742 surrounding cylindrical element 736 andtubular element 738. FIG. 7F shows a cross sectional view of anembodiment of a shaft 744 comprising a tubular member 746 comprising afirst lumen 748 and a second lumen 750; a first coating 752 located onthe outer surface of tubular member 746; a braid 754 located on theouter surface of first coating 752 and a second coating 756 surroundingbraid 754. First lumen 748 is lined with a suitable coating 758 likehydrophilic lubricious coating, hydrophobic lubricious coating, abrasionresisting coating etc. In one embodiment, first lumen 748 is a guidewirelumen and second lumen 750 is an inflation lumen. The lumens disclosedherein can be lined with suitable coatings like hydrophilic lubriciouscoatings, hydrophobic lubricious coatings, abrasion resisting coatings,radiopaque coatings, echogenic coatings etc.

FIG. 7G shows a partial perspective view of an embodiment of a shaft754* comprising a first lumen 756* and a zipper lumen 758*. Zipper lumen758* allows a device like a guidewire 760* to be easily introduced intoor removed from shaft 754*. FIG. 7H shows a cross sectional view throughplane 7H-7H in FIG. 7G showing the orientations of first lumen 756* andzipper lumen 758*.

FIG. 7I shows a cross sectional view of an embodiment of a shaft 762comprising a first lumen 764 and a rapid exchange lumen 766. Rapidexchange lumen 766 extends from the distal end of shaft 762 to aproximal region. Rapid exchange lumen 766 enables shaft 762 to be easilyand quickly introduced or removed over an exchange device like aguidewire 768. FIG. 7J shows a cross sectional view through plane 7J-7Jin FIG. 7I showing first lumen 764 and rapid exchange lumen 766. FIG. 7Kshows a cross sectional view through plane 7K-7K in FIG. 7I showingfirst lumen 764.

FIGS. 7L through 7Q shows perspective and sectional views of lumens forthe devices disclosed herein that are not present throughout the lengthof the devices. FIG. 7L shows a perspective view of a balloon cathetercomprising a shaft 770, a balloon 772 and a lumen 774 that is presentthroughout shaft 770. The balloon catheter further comprises a ballooninflation lumen 776 that opens into balloon 772. The distal end ofballoon inflation lumen 776 is plugged with a plug 778. FIG. 7M shows acrossection through plane 7M-7M in FIG. 7L showing shaft 770 comprisinglumen 774 and balloon inflation lumen 776. FIG. 7N shows a crossectionthrough plane 7N-7N in FIG. 7L showing shaft 770 comprising lumen 774and plug 778. FIG. 7O shows a perspective view of a balloon cathetercomprising a shaft 780, a balloon 782 and a lumen 786 that is presentthroughout shaft 780. The balloon catheter further comprises a ballooninflation lumen 784. The distal end of balloon inflation lumen 784 opensinto balloon 782. FIG. 7P shows a crossection through plane 7P-7P inFIG. 7O showing shaft 780 comprising lumen 786 and balloon inflationlumen 784. FIG. 7Q shows a crossection through plane 7Q-7Q in FIG. 7Oshowing shaft 780 comprising lumen 786.

FIGS. 8A through 8E show partial perspective views of severalembodiments of markers that may be present on the elements of thedevices mentioned herein. FIG. 8A shows a partial perspective view of anembodiment of a shaft 800 comprising a plurality of distance markers 802located along the length of shaft 800. FIG. 8B shows a partialperspective view of an embodiment of a shaft 804 comprising a pluralityof radiographic markers 806 located along the length of shaft 804. FIG.8C shows a partial perspective view of an embodiment of a shaft 808comprising a plurality of ring shaped radiographic markers 810 locatedalong the length of shaft 808. FIG. 8D shows a partial perspective viewof an embodiment of a balloon catheter 812 comprising a shaft 814 and aballoon 816. Balloon 816 comprises a plurality of radiographic markers818 located on the outer surface of the balloon 816. Such markers 818may be in a linear arrangement, non-linear arrangement or any otherconfiguration that performs the desired marking function (e.g.,delineating the length and/or diameter of the balloon, marking theproximal and/or distal ends of the balloon, etc.). FIGS. 8E and 8E′ showpartial perspective and longitudinal sectional views of an embodiment ofa balloon catheter 820 comprising a shaft 822 and a balloon 824. Balloon824 comprises a plurality of radiographic markers 826 located on theinner surface of the balloon 824. Such markers 826 may be in a lineararrangement, non-linear arrangement or any other configuration thatperforms the desired marking function (e.g., delineating the lengthand/or diameter of the balloon, marking the proximal and/or distal endsof the balloon, etc.). The devices disclosed herein may also compriseseveral other types of markers like ultrasound markers, radiofrequencymarkers and magnetic markers. Similarly, the devices disclosed hereinmay also comprise one or more sensors like electromagnetic sensors,electrical sensors, magnetic sensors, light sensors and ultrasoundsensors.

The term “diagnostic or therapeutic substance” as used herein is to bebroadly construed to include any feasible drugs, prodrugs, proteins,gene therapy preparations, cells, diagnostic agents, contrast or imagingagents, biologicals, etc. Such substances may be in bound or free form,liquid or solid, colloid or other suspension, solution or may be in theform of a gas or other fluid or nan-fluid. For example, in someapplications where it is desired to treat or prevent a microbialinfection, the substance delivered may comprise pharmaceuticallyacceptable salt or dosage form of an antimicrobial agent (e.g.,antibiotic, antiviral, antiparasitic, antifungal, etc.), acorticosteroid or other anti-inflammatory (e.g., an NSAID), adecongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., anexpectorant or mucolytic), an agent that prevents of modifies anallergic response (e.g., an antihistamine, cytokine inhibitor,leucotriene inhibitor, IgE inhibitor, immunomodulator), etc. Othernon-limiting examples of diagnostic or therapeutic substances that maybe useable in this invention are described in copending U.S. patentapplication Ser. No. 10/912,578 entitled Implantable Devices and Methodsfor Delivering Drugs and Other Substances to Treat Sinusitis and OtherDisorders filed on Aug. 4, 2004, issued as U.S. Pat. No. 7,361,168 onApr. 22, 2008, the entire disclosure of which is expressly incorporatedherein by reference.

The term “nasal cavity” used herein to be broadly construed to includeany cavity that is present in the anatomical structures of the nasalregion including the nostrils and paranasal sinuses.

The term “trans-nasal” means through a nostril.

Although the methods and devices disclosed herein are illustrated inconjunction with particular paranasal sinuses, it is understood thatthese methods and devices can be used in other paranasal sinuses as wellas other anatomical passageways of the ear, nose or throat.

Optionally, any of the working devices and guide catheters describedherein may be configured or equipped to receive or be advanced over aguidewire or other guide member (e.g., an elongate probe, strand ofsuture material, other elongate member) unless to do so would render thedevice inoperable for its intended purpose. Some of the specificexamples described herein include guidewires, but it is to beappreciated that the use of guidewires and the incorporation ofguidewire lumens is not limited to only the specific examples in whichguidewires or guidewire lumens are shown. The guidewires used in thisinvention may be constructed and coated as is common in the art ofcardiology. This may include the use of coils, tapered or non-taperedcore wires, radioopaque tips and/or entire lengths, shaping ribbons,variations of stiffness, PTFE, silicone, hydrophilic coatings, polymercoatings, etc. For the scope of this invention, these wires may possessdimensions of length between 5 and 75 cm and outer diameter between0.005″ and 0.050″.

Several modalities can be used with the devices and methods disclosedherein for navigation and imaging of the devices within the anatomy. Forexample, the devices disclosed herein may comprise an endoscope forvisualization of the target anatomy. The devices may also compriseultrasound imaging modalities to image the anatomical passageways andother anatomical structures. The devices disclosed herein may compriseone or more magnetic elements especially on the distal end of thedevices. Such magnetic elements may be used to navigate through theanatomy by using external magnetic fields. Such navigation may becontrolled digitally using a computer interface. The devices disclosedherein may also comprise one or more markers (e.g. infra-red markers).The markers can be used to track the precise position and orientation ofthe devices using image guidance techniques. Several other imaging ornavigating modalities including but not limited to fluoroscopic,radiofrequency localization, electromagnetic, magnetic and otherradiative energy based modalities may also be used with the methods anddevices disclosed herein. These imaging and navigation technologies mayalso be referenced by computer directly or indirectly to pre-existing orsimultaneously created 3-D or 2D data sets which help the doctor placethe devices within the appropriate region of the anatomy.

The distal tip of devices mentioned herein may comprise a flexible tipor a soft, atraumatic tip. Also, the shaft of such devices may bedesigned for enhanced torquability.

The embodiments herein have been described primarily in conjunction withminimally invasive procedures, but they can also be used advantageouslywith existing open surgery or laparoscopic surgery techniques.

It is to be appreciated that the invention has been described hereabovewith reference to certain examples or embodiments of the invention butthat various additions, deletions, alterations and modifications may bemade to those examples and embodiments without departing from theintended spirit and scope of the invention. For example, any element orattribute of one embodiment or example may be incorporated into or usedwith another embodiment or example, unless to do so would render theembodiment or example unsuitable for its intended use. All reasonableadditions, deletions, modifications and alterations are to be consideredequivalents of the described examples and embodiments and are to beincluded within the scope of the following claims.

What is claimed is:
 1. A device for treating a patient, the devicecomprising: (a) an elongate shaft comprising an open proximal end, anopen distal end including a tip, an exterior surface, and an outerdiameter sized to allow the shaft to be inserted into a patient's nose,wherein at least a portion of the shaft extends along an axis; (b) atreatment member coupled with the shaft at or near the tip, wherein theshaft includes a flexible portion, wherein at least a portion of theflexible portion is coincident with the treatment member such that atleast a portion of the tip is deflectable between a first position wherethe tip is oriented at a first angle relative to the axis, and a secondposition where the tip is oriented at a second angle relative to theaxis; (c) a steering wire coupled with the treatment member such that aportion of the steering wire can be retracted into the treatment memberand advanced from the treatment member; (d) a handle extending from theproximal end of the elongate shaft; and (e) a control element movablycoupled with the handle and the steering wire, wherein the controlelement is movable in a first direction to thereby retract the portionof the steering wire, wherein the control element is movable in a seconddirection to thereby advance the portion of the steering wire.
 2. Thedevice of claim 1, wherein the treatment member is selected from thegroup consisting of balloon catheters, rotating cutters, high frequencymechanical vibrators, rotating drills, sequential dilators, tapereddilators, punches, electrocautery devices, cutters, mechanicallyexpandable members, dilating stents and devices that introducediagnostic or therapeutic agents.
 3. The device of claim 1, wherein thefirst angle is approximately zero degrees.
 4. The device of claim 1,wherein the elongate shaft further comprises a guidewire lumen.
 5. Thedevice of claim 1, further comprising at least one shaft stiffeningmember removably coupled with the shaft for stiffening the flexibleportion.
 6. The device of claim 5, wherein the at least one shaftstiffening member comprises an external stiffening element.
 7. Thedevice of claim 5, wherein the at least one shaft stiffening member isselected from the group consisting of stylets, spiral wires, braids,stiffening wires, stiffening rings, stiffening coatings, stiffeningmeshes, and removably insertable stiffening elements.
 8. The device ofclaim 1, wherein the elongate shaft comprises a catheter and thetreatment member comprises an inflatable member.
 9. The device of claim8, wherein the shaft further comprises an inflation lumen incommunication with the inflatable member.
 10. The device of claim 9,wherein the shaft further comprises a guidewire lumen for receiving aguidewire.
 11. The device of claim 1, wherein the elongate shaft definesat least one lumen.
 12. The device of claim 11, further comprising amalleable member insertable into the at least one lumen, wherein themalleable member is configured to impart malleability to the elongateshaft when the malleable member is inserted into the at least one lumen.13. The device of claim 11, further comprising an insertable element,wherein the insertable element has a pre-formed shape, wherein the shaftis configured to assume the pre-formed shape of the insertable elementwhen the insertable element is inserted into the at least one lumen. 14.The device of claim 1, further comprising a tensile element coupled tothe distal end portion of the shaft, wherein the shaft is configured tobend in response to the tensile element being pulled in the proximaldirection.
 15. The device of claim 1, wherein the tip is configured toreturn to the first position when the second portion of the deflectingmember is moved distally.
 16. The device of claim 1, further comprisingat least one shaft stiffening member coupled with the elongate shaft forstiffening the flexible portion; wherein the shaft stiffening member isconfigured to transition between a first position and second position;wherein the flexible portion of the elongate shaft is flexible when theat least one shaft stiffening member is in the first position; whereinthe flexible portion of the elongate shaft is stiff when the at leastone shaft stiffening member is in the second position; and wherein thetip is configured to be deflected when the flexible portion of theelongate shaft is flexible.
 17. A device for treating a patient, thedevice comprising: (a) a treatment member; (b) a shaft coupled with thetreatment member, wherein the shaft comprises: (i) a proximal end, (ii)a distal end, (iii) an exterior surface, (iv) a tip disposed on thedistal end and having an outer diameter sized to allow the shaft to beinserted into a patient's nose, and (v) a flexible portion coincidentwith the treatment member and coupled with the tip, wherein the flexibleportion is configured to deflect the tip between a first position and asecond position; (c) a handle extending from the shaft; (d) a steeringwire coaxial with the treatment member, wherein the steering wire ismovable between a first steering position and a second steeringposition; and (e) a slide element, wherein the slide element is slidablycoupled with the handle and the steering wire, wherein the slide elementis movable between a first slide position and a second slide position,wherein the slide element is operable to move the steering wire to thefirst steering position in response to movement of the slide element tothe first slide position, wherein the slide element is operable to movethe steering wire to the second steering position in response tomovement of the slide element to the second slide position.
 18. A devicefor treating a patient, the device comprising: (a) an elongate, at leastpartially flexible shaft comprising: (i) a proximal end, (ii) a distalend, (iii) a tip at or near the distal end, and (iv) a flexible portionat or near the distal end, wherein at least a portion of the shaftextends along an axis; (b) a treatment member coupled with the shaft,wherein the flexible portion of the shaft is coincident with thetreatment member such that at least a portion of the tip is deflectablebetween a first angle relative to the axis and a second angle relativeto the axis; (c) a steering wire coincident with the treatment memberand configured to be selectively advanced and retracted therethrough;and (e) a thumb slide, wherein the thumb slide is coupled with thesteering wire and movable along a track.
 19. The device of claim 18,wherein the thumb slide is operable to advance the steering wire inresponse to movement of the thumb slide in a first direction.
 20. Thedevice of claim 19, wherein the thumb slide is operable to retract thesteering wire in response to movement of the thumb slide to a seconddirection.